Currently, in the pharmacological treatment of Diabetes Mellitus, there is use of insulin and groups of hypoglycemic agents such as the Sulfonylureas, the Biguanides, α-glucosidase inhibitors and Thiazolidinedione derivatives, whose action mechanism works by either stimulating the secretion of insulin or increasing the action of this hormone on the bodily tissues. The half-life of these drugs varies from 1.5 to 48 hours. Although all these drugs, by different action mechanisms, regulate the concentration of blood glucose and/or the secretion of insulin, the duration of their effect is a short period of time and none of them carries out the regeneration of the β-pancreatic cells that produce insulin and that allow the restoration of the function of this hormone. On the other hand, both exogenous insulin and hypoglycemic agents can cause side effects, such as: hypoglycemia, diarrhea, abdominal upsets, nausea and anorexia (Davis, S. and Granner, D., Insulin, Oral Hypoglycemic Agents and the Pharmacology of the Endogenous Pancreas. In: The Pharmacological Basis of Therapeutics. Eds.: Hardman, J. G., Limbird, L. E., Molinoff, P. B., Ruddon, R. W., Goodman, R., 8th Ed. pp. 1581-1614, 1996).
None of the medication used currently for the treatment of Diabetes Mellitus regenerates either damaged tissues or cells of endogenous secretion, including the β-pancreatic cells, as the Silymarin and Carbopol compound does. Both in vitro and in vivo, it has been demonstrated that Silymarin has a protective and regenerative activity on the hepatic cells against the damage produced by different toxic substances such as: phalloidin, α-amanitin, alcohol, galactosamine, heavy metals, carbon tetrachloride, toluene, xylene or by certain drugs such as: acetaminophen, indomethacin, isoniazid and tolbutamide (Wellington, K., Harvis, B., Silymarin: A review of its clinical properties in the management of hepatic disorders. Biodrugs. 15: 465-489, 2001) since it has been shown to stabilize the cellular membrane and protect it against free radicals, i.e., it has antioxidative properties by producing an increase in the hepatic glutathione content (free radical scavenger) (Valenzuela, A., Garrido, A. Biochemical basis of the pharmacological action of the flavonoid silymarin and of its structural isomer silibinin. Biol. Res. 27:105-112, 1994).
In humans, Silymarin has been used to treat hepatic diseases such as cirrhosis, poisoning by the fungus Amanita phalloides and exposure to toxic substances (Wellington, K., Harvis, B., Silymarin: A review of its clinical properties in the management of hepatic disorders. Biodrugs. 15: 465-489, 2001).
It has been suggested that free radicals play an important role in the etiology of Diabetes Mellitus, since high serum levels of malondialdehyde (end product of lipoperoxidation) in patients with this disease (Paolisso G, De Amore, A, Di Maro G, D'Onofrio F: Evidence for a relationship between free radicals and insulin action in the elderly. Metabolism, 42:659-66, 1993). Such levels of malondialdehyde are in direct relation to the degree of complications present in patients with Diabetes Mellitus. Defense mechanisms against free radicals include glutathione and antioxidant enzymes such as superoxide dismutase, glutathione peroxidase and catalase. Soto et al. (Soto C, Pérez B, Favari L, Reyes J: Prevention of alloxan-induced diabetes mellitus in the rat by silymarin. Comp. Biochem. Physiol. 119C:125-129, 1998) reported that Silymarin increases the pancreatic and hepatic glutathione content and therefore its level in blood.
The authors of the aforementioned work also found that Silymarin impeded the elevation of free radicals in the pancreas during the induction of Diabetes Mellitus, which led to a reduction of the blood glucose which is found to be high in this disease.
Taking into consideration the background described, the compound of Silymarin and Carbopol was used as an antidiabetic agent which it is sought to be protected through this application, since it presented an unknown effect as a pancreatic regenerator and controller of the serum concentration of the glucose, which is not regulated in diabetic patients.